# K102783: Hinson & Hale Medical Technologies Infused (R) Polyester Wrappers

- Pathway: 510(k) (Traditional)
- Applicant: Hinson and Hale Medical Technologies, Inc.
- Decided: Dec 22, 2010 after 86 days
- Product code: FRG (Wrap, Sterilization)
- Device class: 2
- Regulation: 21 CFR 880.6850
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The Hinson and Hale Medical Technologies, Inc. Infused® Polyester Wrappers, Models PJ2020 and SP3158, are devices intended to be used to enclose another medical device that is to be sterilized by a health care provider. It is intended to allow sterilization of the enclosed medical device and also to maintain sterility of the enclosed device up until 30 days. The Hinson and Hale Medical Technologies, Inc. Infused® Polyester Wrappers, Models PJ2020 and SP3158, are provided non-sterile and must be processed before use. These wrappers may be reprocessed for a total of 100 uses when laundered and sterilized according to the label and instructions provided with the product. Reprocessing instructions are based on industrial laundering procedures and steam sterilization (pre-vacuum, 270oF, 4 minutes with 20 minutes drying time).

Source page: https://510kreport.com/device/K102783
Methodology: https://510kreport.com/methodology